Digital Clinical Hypnosis for Chronic Lower Back Pain

Overseen By Joy Chan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Psychotic disorders, Psychiatric hospitalization, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing hypnosis audio recordings, so it's likely you can continue your medications, but please confirm with the study team.

What data supports the effectiveness of the treatment Digital Clinical Hypnosis for chronic lower back pain?

Research suggests that hypnosis can help reduce pain intensity and improve mood in people with chronic low back pain, although the long-term benefits are unclear. Studies have shown that both hypnosis and relaxation techniques can significantly decrease pain and depression levels, and hypnosis may also help with sleep and medication use. ^{1 2 3 4 5}

Is digital clinical hypnosis generally safe for humans?

Hypnosis is generally considered safe, with a very low rate of adverse events reported in clinical trials. Serious adverse events are rare, and the rate of other adverse events is about 0.47%, similar to other reports. ^{4 6 7 8 9}

How is Digital Clinical Hypnosis different from other treatments for chronic lower back pain?

Digital Clinical Hypnosis is unique because it uses hypnosis, a mind-body technique, to help manage chronic lower back pain, potentially reducing pain intensity and improving mood. Unlike traditional treatments that may involve medication or physical therapy, this approach focuses on mental relaxation and self-hypnosis, which can be practiced at home and may offer a holistic way to address pain. ^{1 2 3 4 10}

What is the purpose of this trial?

This study is a randomized controlled trial that plans to enroll 50 adults with chronic low back pain. Participants will be in the study for 8 weeks and the study aim is to test different combinations hypnosis audio recordings to see which recordings participants like the best and lead to greatest reductions in pain. The investigators hope to develop a mobile app using participants' feedback to make hypnosis treatment for chronic pain more widely available. The investigators plan to develop and commercialize this app through HypnoScientific Inc., a company that is co-owned by the investigators. Participants will complete brief (15-20min) surveys that ask about pain and mental health at three timepoints: Baseline (week 0), 4 weeks, and 8 weeks.

Research Team

Mark Jensen, MD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for adults over 18 with chronic low back pain lasting more than 3 months, who rate their pain at least a 4 out of 10. Participants must speak English, have internet access, and own a device compatible with the digital therapeutic.

Inclusion Criteria

I have had chronic low back pain for more than 3 months.

You possess consistent internet access as revealed through self-reporting.

My average pain level in the past week was 4 or higher on a scale of 0 to 10.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive access to online hypnosis recordings for pain management

8 weeks

3 visits (virtual) at Baseline, 4 weeks, and 8 weeks

Waitlist Control

Participants are on a waitlist for 4 weeks before receiving access to hypnosis recordings

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Digital Clinical Hypnosis

Trial Overview The study tests different hypnosis audio recordings to see which are preferred by participants and most effective in reducing chronic low back pain. The goal is to create an app based on feedback that can help manage chronic pain.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

8 weeks of access to online hypnosis recordings

Group II: Waitlist Control Active Control 1 Intervention

4 weeks of waitlist (no access to recordings) and then 4 weeks of access to hypnosis recordings

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

The study involved 45 patients with chronic low back pain who participated in a pain control course that included education about pain and self-hypnosis, but neither component showed a significant difference in effectiveness on pain intensity or psychological measures.

While the treatment did not significantly reduce pain intensity, it led to meaningful improvements in coping strategies and psychological well-being, suggesting that teaching patients to manage their pain may be a more realistic goal than solely focusing on pain reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education and self-hypnosis in the management of low back pain: a component analysis. Spinhoven, P., Linssen, AC.[2019]

Hypnosis is generally a safe treatment method, but adverse effects can occur during clinical and workshop settings, highlighting the need for enhanced safety measures.

The article identifies 9 categories of adverse events that can arise in hypnosis workshops and discusses factors that may prevent these incidents from being recognized or reported, emphasizing the importance of awareness and proactive modifications to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Issues in the detection of those suffering adverse effects in hypnosis training workshops. Kluft, RP.[2015]

A survey of hypnosis clinicians revealed discrepancies between research evidence and actual clinical practice, particularly regarding the effectiveness of hypnosis for various conditions and the occurrence of adverse events during treatment.

The study suggests improvements in hypnosis training, including better monitoring of adverse events, enhanced methods for addressing trauma-related symptoms, and support for clinician competency development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Connections between Clinicians and Research in Hypnosis Practice: Strategies for Practice and Training. McKernan, LC., Walsh, EG.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Hypnosis treatment for chronic low back pain. [2010]

2. United States pubmed.ncbi.nlm.nih.gov

Hypnosis compared to relaxation in the outpatient management of chronic low back pain. [2008]

3. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of hypnosis compared with biofeedback for adults with chronic low back pain. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effects of osteopathic manipulative treatment associated with pain education and clinical hypnosis in individuals with chronic low back pain: study protocol for a randomized sham-controlled clinical trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Education and self-hypnosis in the management of low back pain: a component analysis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Issues in the detection of those suffering adverse effects in hypnosis training workshops. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Enhancing Connections between Clinicians and Research in Hypnosis Practice: Strategies for Practice and Training. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Inadvertent adverse consequences of clinical and forensic hypnosis: minimizing the risks. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

The Rate of Adverse Events Related to Hypnosis During Clinical Trials. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Hypnosis As A Therapy for Chronic Lower Back Pain. [2022]